Precise Percutaneous Coronary Intervention Plan (P3) Study (P3)

Prospective Evaluation of a Virtual Non-invasive Percutaneous Intervention Planner in Patients With Coronary Artery Disease.

The PRECISE PERCUTANEOUS CORONARY INTERVENTION (PCI) PLAN STUDY is an investigator-initiated, international and multicenter study of patients with an indication for PCI aiming at assessing the agreement and accuracy of the HeartFlow Planner with invasive fractional flow reserve (FFR) as a reference.

Study Overview

• Status: Completed
• Conditions: Stable Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: FFRCT planner

Detailed Description

Multicenter study, including 120 patients at 5 centers in Europe and Asia. After identifying the presence of significant coronary stenosis by means of coronary angiography and invasive fractional flow reserve (FFR≤0.80) the patients will undergo the following procedures: Invasive FFR with intravenous adenosine (i.e. pre- and post-PCI). Optical coherence tomography-guided PCI (i.e. pre- and post-procedural imaging). PCI with newer generation drug-eluting stent.

• Study Type: Observational
• Enrollment (Actual): 127

Contacts and Locations

Study Locations

• Belgium
  • Oost-Vlaanderen
    • Aalst, Oost-Vlaanderen, Belgium, 9300
      • OLV-Aalst

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Stable Coronary Artery Disease with Positive Fractional Flow Reserve and indication for percutaneous myocardial revascularization.

Description

Inclusion Criteria:

• Coronary artery disease in a major epicardial vessel with an invasive fractional flow reserve (FFR) ≤0.80
• An indication to Percutaneous coronary intervention

Exclusion Criteria:

- Angiographic exclusion criteria

1. Severely calcified lesion/vessel
2. Bifurcation lesions.
3. Ostial lesions.
4. Left main disease.
5. Severe vessel tortuosity.

Clinical exclusion criteria

1. Chronic obstructive pulmonary disease
2. Contraindication to adenosine
3. NYHA class III or IV, or last known left ventricular ejection fraction <30%
4. Uncontrolled or recurrent ventricular tachycardia
5. Atrial fibrillation, flutter or arrhythmia
6. History of recent stroke (≤90 days)
7. History of acute coronary syndrome (≤90 days)
8. Prior myocardial infarction
9. History of ischemic stroke (>90 days) with modified RANKIN score ≥ 2
10. History of any hemorrhagic stroke
11. Previous revascularization (PCI or Coronary artery bypass grafting)
12. Active liver disease or hepatic dysfunction, defined as AST or ALT > 3 times the ULN
13. Severe renal dysfunction, defined as an eGFR <30 mL/min/1.73 m2
14. Body mass index>35 kg/m2
15. Nitrate intolerance

16. Contra-indication to heart rate lowering drugs

    Imaging-related

17. Insufficient coronary CT Angiography image quality.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single-arm cohort; Patients with significant coronary stenosis by invasive fractional flow reserve (FFR≤0.80)	Diagnostic test: FFRCT planner; Non-invasive post-PCI fractional flow reserve prediction; Other Names: HeartFlow Planner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement on post-PCI fractional flow reserve between virtual treatment based on FFRct planner and measured invasive post-PCI fractional flow reserve.	The agreement will be assessed by Bland Altman method	The primary endpoint will be assessed immediately after the procedure (PCI).

Collaborators and Investigators

• Sponsor: Onze Lieve Vrouw Hospital

Publications and helpful links

General Publications

• Sonck J, Nagumo S, Norgaard BL, Otake H, Ko B, Zhang J, Mizukami T, Maeng M, Andreini D, Takahashi Y, Jensen JM, Ihdayhid A, Heggermont W, Barbato E, Mileva N, Munhoz D, Bartunek J, Updegrove A, Collinsworth A, Penicka M, Van Hoe L, Leipsic J, Koo BK, De Bruyne B, Collet C. Clinical Validation of a Virtual Planner for Coronary Interventions Based on Coronary CT Angiography. JACC Cardiovasc Imaging. 2022 Jul;15(7):1242-1255. doi: 10.1016/j.jcmg.2022.02.003. Epub 2022 Apr 13.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): December 18, 2020
• Study Completion (Actual): December 18, 2021

Study Registration Dates

• First Submitted: December 12, 2018
• First Submitted That Met QC Criteria: December 19, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: CVBA-CRI_0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided plan for data sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No